Complaint Engineer, Randstad

Complaint Engineer

Randstad

Location:

Switzerland, Le Locle

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

We are looking for a Complaint Engineer 100% for one of our clients in the canton of Neuchatel. If you want to work in a nice and dynamic environment in the medical devices industry then this position is made for you!

Job Responsibility:

Manage complaint investigation: communication with intake service, decontamination process, complaint investigation (analysis in laboratory, dimensional analysis, physical-chemical analysis, and any other necessary tests for product investigation and cause identification), review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicable
Implement and improve procedures related to complaints in accordance with applicable regulations/standards/requirements
Track Corrective/Preventive/Improvement Actions
Participate to projects related to complaints activities
Raise awareness among other departments on complaints processing
Track indicators
Apply procedures related to complaints and material vigilance
Ensure adequate investigation of the complaints with relevant stakeholders (production, engineering, PD, QE, etc.)
Review, approve and close complaint investigations for Le Locle
Implementation and management of complaints procedures, investigation, trending, and product surveillance
Perform et review complaint trend analysis according to relevant GSOPs
Management of Health Hazard Evaluation: complete documentation in coordination with relevant stakeholders (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance)
Participate to Post Market Surveillance activities : provide data
Participate to risk management analysis activities according to procedures and within the defined timeline
Participate and support internal audits and third party audits / inspections

Requirements:

Minimum of Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline
Minimum of 2 years of professional work experience within a quality assurance or compliance audit environment is required
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.
Experience in a Medical Device manufacturing environment is preferred
Training in laboratory techniques in medical
Teamwork ability
Ability to interface with internal and external customers
Communication, organizational, negotiation and interpersonal skills
Risk management knowledge
Root cause analysis methods
Fluent in English and French
Use of Microsoft office tools

Additional Information:

Job Posted:

March 31, 2025

Expiration:

May 31, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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